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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM

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NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM Back to Search Results
Model Number NX1000-3
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Calcium Deposits/Calcification (1758); Chest Pain (1776); Dyspnea (1816); Edema (1820); Pain (1994); Regurgitation (2259); Respiratory Failure (2484)
Event Date 10/09/2019
Event Type  Injury  
Manufacturer Narrative
The product meets all quality criteria and manufacturing specifications prior to release. The system one user guide includes fluid overload as a known and common risk associated with hemodialysis therapy and warns that hemodialysis may result in significant changes in the blood concentration of electrolytes and glucose and in the patient¿s volume status. Appropriate monitoring of the patient¿s hemodynamic, fluid, electrolyte, and acid-base balance should be performed regularly, per physician orders, to ensure appropriate response to therapy. Failure to do so could result in inappropriate therapy for the patient.
 
Event Description
A report was received on 02 nov 2019 from the caregiver regarding a (b)(6) male with medical history significant for end-stage renal disease, ~27 year history of type i diabetes, obesity, hypertension, low cardiac ejection fraction, an implantable cardioverter defibrillator (icd) with recent shock delivered and paroxysmal atrial fibrillation, stating an insufficient amount of programmed fluid was removed during home hemodialysis treatments. Per the caregiver, the patient had fluid overload and other lab values were out of range. Additional information was received on 07 nov 2019 from the home therapy nurse (htn) which revealed the patient had received a shock from his icd on (b)(6) 2019 unrelated to hemodialysis therapy. On (b)(6) 2019 the patient experienced acute chest pain, shortness of breath (o2 stat low 80s), acute respiratory failure with hypoxia, a-fib with rvr (hr 150-160) and fluid overload, and was admitted to hospital. Ecg performed on (b)(6) 2019 showed left axis deviation and left ventricular hypertrophy, cardiac echocardiogram showed the presence of hypokinesis, enlarged ventricles, calcification, valve thickening and regurgitation, cxr showed low lung volumes, physical examination confirmed the presence of rales and bilateral pitting edema of the legs, and lab results showed out of range results including low k+, calcium, sodium, hemoglobin and hematocrit. The patient received oxygen, electrolyte replacement, was commenced on oral eliquis 2. 5mg bd, and had hemodialysis performed for 3 consecutive days. The patient was discharged (b)(6) 2019 with a discharge diagnosis of paroxysmal atrial fibrillation and acute respiratory failure with low oxygen, and continues to treat using the nxstage system one.
 
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Brand NameNXSTAGE SYSTEM ONE
Type of DeviceHIGH PERMEABILITY HEMODIALYSIS SYSTEM
Manufacturer (Section D)
NXSTAGE MEDICAL, INC.
350 merrimack street
lawrence MA 01843
Manufacturer (Section G)
MEDIMEXICO S. DE R. L. DE C. V
av. valle imperial no. 10523
parque industrial valle sur
tijuana 22180
MX 22180
Manufacturer Contact
paula rogalski
nxstage medical, inc
350 merrimack street
lawrence, MA 01843
9784505276
MDR Report Key9384882
MDR Text Key168440380
Report Number3003464075-2019-00070
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K122051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,11/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-3
Device Catalogue NumberCHRONIC HI-FLOW CYCLER
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received11/02/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/27/2019 Patient Sequence Number: 1
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